EVALUATION OF SUBCHRONIC (13 WEEK), REPRODUCTIVE, AND IN-VITRO GENETIC TOXICITY POTENTIAL OF 2-ETHYLHEXYL-2-CYANO-3,3-DIPHENYL ACRYLATE (OCTOCRYLENE)

Use of 2-ethylhexyl-2-cyano-3,3-diphenyl acrylate (Octocrylene) in com mercial sunscreen products has increased considerably in recent years. To support larger scale human exposure to this compound, additional t oxicological information was needed in several key areas. The present studies evaluated subchronic toxicity, developmental toxicity, and in vitro genotoxic potential of Octocrylene. In the subchronic study, mal e and female New Zealand white (NZW) rabbits treated topically with co ncentrations of octocrylene up to 534 mg/kg/day for 13 weeks showed sl ight to moderate dose-dependent skin irritation that correlated positi vely with a mild depression in body weight gain. Lack of associated hi stopathologic or clinical hematology abnormalities suggested that the body weight effect probably reflected a nonspecific response to topica l irritation. In percutaneous developmental toxicity studies, NZW does were treated topically with Octocrylene at levels up to 267 mg/kg/day on Days 6 through 18 of gestation. Body weight gain, food consumption , and all maternal, reproductive, and offspring parameters evaluated w ere comparable between Octocrylene-treated and control animals. In the oral developmental toxicity assay, female CD-1 mice received oral dos es of Octocrylene up to 1000 mg/kg/day on Days 8-12 of gestation. No e vidence of maternal or developmental toxicity was seen at any dose tes ted. Genotoxicity was evaluated in vitro using the Chinese hamster ova ry cell assay to assess clastogenicity and the mouse lymphoma cell ass ay to assess forward gene mutations. Octocrylene did not induce any si gnificant increase in genotoxicity. This evaluation of toxicological p otential supports the use of Octocrylene as a human photoprotectant. ( C) 1994 Society of Toxicology.